Clinical Trials Manager

At Houston Methodist Department of Urology, the Manager Clinical Trials position is responsible for managing complex research projects that may involve single or multiple research teams conducting research activities. This position directly supervises research staff to ensure effective planning, oversight and coordination of clinical research projects. Research projects in the department are a combination of investigator initiated, industry funded and extramural grant funded. The Manager Clinical Trials position monitors progress and performance of all projects to include quality of services, timelines, financial viability, compliance with federal, state and/or other regulations, laws and guidelines of Houston Methodist Research Institute (HMRI). This position provides guidance to department and HMRI leadership on relevant clinical trial issues and development.

The manager position responsibilities include managing the daily work activities of the work unit/department staff, ensuring quality, productivity, functional excellence and efficiency while assisting management in accomplishing strategic and operational objectives. In addition, this position provides guidance to staff and is responsible for staffing, budget compliance, contributing to staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and assisting in the development and implementation of policies and procedures to ensure a safe and effective work environment. This position also implements training, monitoring and operations initiatives that secure compliance with ethical and legal business practices and accreditation/regulatory/ government regulations.

Work Experience:
Five years of experience in the field, of which one year must have been in the managerial role in healthcare; For internals, four years of experience in relevant field with HM performance that demonstrated leadership abilities.
Preference will be given to applicants who have background in Urology and or Oncology clinical trials. Preference will also be given to candidates who have additional experience in managing extramural grant funded research.

PEOPLE ESSENTIAL FUNCTIONS

Performs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in the department. Provides development and mentoring of staff. Meets or exceeds threshold goal for department turnover. Develops direct reports to perform these same functions.

Provides fair and consistent leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem.

Facilitates and promotes effective team dynamics and teambuilding strategies within and between departments; participates and/or leads and facilitates department process improvements as needed.

Meets or exceeds threshold goal for department and/or system metrics on employee engagement indicators.

Assists with on-boarding of new employees including sequencing and executing tasks/actions involving Houston Methodist Research Institute/Houston Methodist Hospital (HMRI/HMH) support areas (e.g. Department Orientation, Uniforms, Telecom/IT, Equipment, Supplies, Training, HMRI Credentialing/Competency, etc.)

SERVICE ESSENTIAL FUNCTIONS

Plans and organizes day-to-day department operations, schedule and activities. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction.

Drives department service standards and activities to impact department and/or system score for patient/customer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department.

Implements complex research projects, including screening and enrolling subjects, and conducting testing procedures required by study protocol (medical history interview, vital signs, collect and enter data into case report forms, reporting to study monitors), prepares presentations and schedules institutional training for physicians, nurses, and staff on research protocol.

Establishes consistent productivity expectations and revises as needed. Makes recommendations to department leadership regarding staffing requirements to meet needs of the research team to achieve maximum productivity.

Identifies operational problems, issues and barriers across projects with input from investigators, research team members, and sponsors; communicate patterns and trends to department and HMRI leadership as appropriate; supports efforts to develop and implement process/system improvements.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines, including infection control principles. Monitors and confirms staff maintain their required credentials that demonstrate competency per accrediting agency or department guidelines as applicable.

Uses and optimizes information systems to enhance operations; supports entity-specific performance improvement and data management/analysis functions.

Employs a proactive approach in the optimization of safe outcomes by monitoring and improving the department workflow, using peer-to-peer accountability, reporting accidents, near misses, and/or adverse events immediately per department protocol and identifying solutions via collaboration. Adopts lean principles in driving process improvements. Role models situational awareness, using teachable moments to improve safety.

Monitors self and employee compliance with policies, procedures, and System HR Standards of Practice and performs associated actions upon non-compliance (i.e., focal point review requirements, disaster plan, inservices, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.).

Monitors site visits pre-study, at study initiation, at regular intervals during the study and at study closeout.

Conduct study operational feasibility assessments and risk assessments, along with assessing ongoing training needs of the research team.

Monitors progress and performance of all projects including quality of services, financial viability, and compliance with federal, state, and/or other regulations and laws including guidelines of HMRI.

Assures proper study documentation is maintained and archived.

FINANCE ESSENTIAL FUNCTIONS

Assists in the development of department budget and ensures that the department operates in a cost effective manner. Manages/audits department expenses within approved budget parameters, ensuring that the department meets the budgeted/flex revenue and/or expense targets on a monthly and annual basis. Develops staffing plans and schedules to meet department/patient needs that reflect understanding of the importance of cost-effectiveness.

Implements department strategies to achieve financial target and staffing needs, developing others to do the same, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

Identifies and implements innovative solutions for practice or workflow changes to improve department operations or other department-specific measures by leading unit projects and/or other department/system directed/shared governance activities. Supports change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures.

Proactively evaluates processes; recommends and implements action plan(s) for change; follows through to ensure effective, sustainable change. Participates in the development and implementation of new procedures and the review and revision of existing procedures.

Identifies opportunities and takes action to build strategic relationships between one's area and other areas, teams, departments, and units to achieve business goals.

Seeks opportunities to identify developmental needs of self and staff and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates My Development Plan (MDP) on an on-going basis. Conducts conversations with staff on their development.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

EDUCATION

Bachelor's degree in scientific discipline/life sciences (or relevant field) or nursing degree (BSN) required depending on the therapeutic area served

Master's preferred

WORK EXPERIENCE

Five years of experience within the field, of which one year must have been in a managerial role in healthcare; for internals,

Four years of experience in relevant field with HM performance that demonstrates leadership abilities
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